Class 2 Device Recall

• Date Initiated by Firm: August 20, 2004
• Date Posted: October 28, 2004
• Recall Status: Terminated on June 09, 2005
• Recall Number: Z-0053-05
• Recall Event ID: 30013
• 510(K)Number: K802117
• Product Classification: Test, Thrombin Time - Product Code GJA
• Product: MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
• Code Information: Product number 252560, Lot number 505046
• FEI Number: 3002769706
• Recalling Firm/ Manufacturer: bioMerieux; 100 Rodolphe St Bldg 1300; Durham NC 27712-9402
• For Additional Information Contact: Jocelyn Jennings; 919-620-2968
• Manufacturer Reason for Recall: Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 8/20/2004.
• Quantity in Commerce: 1165 units
• Distribution: Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GJA